Senior Executive (Technical Operations)
Primary Job Responsibilities:
- Scale Up/ Scale Down: Batch size change of the existing product in such a way resulting in Line balancing & optimum capacity utilization of line and equipment.
- Transfer of product from one line to another using scaleup factor using different process engineering tools i.e. mixing in RMG/ Blender, dwell time calculation in compression and mass balancing in coater.
- Troubleshooting regular commercial products to support timely deliverance.
- Process simplification/ improvement at the manufacturing and packing stage to reduce cycle time and improve compliance.
- Recipe Finalization of product at different stages to have better process control, product consistency, and reproducibility.
- CMC remediation of the identified products having consistent process/ analytical/ stability issues.
- Process Capability improvement of the identified product having CpK<1.3 for CQA.
- Cost-saving initiatives: Cost-saving projects in competition through Yield improvement, AVD, and cycle time reduction.
- Alternate Vendor Development: Specification designing/ updation for effective and right-first-time implementation of the alternate vendors.
- Technical support for evaluation, trial, and validation with new vendors.
- Provide technical input while selecting new equipment considering process nature and product demand.
- Basic understanding of Packaging development and Troubleshooting for any packaging-related issue observed during blister/ strip/ bulk or bottle packing.
- Analytical method development: Experience in product analytical method development/transfer and any technical input required for smooth transfer including troubleshooting.
Product technology transfer
From Innovation and Development (I & D Mumbai):
- Act as a receiving team for new products transferred from I & D to AHPL, Baddi.
- Right first-time internalization of I&D transfer products to Baddi and its life cycle management after a successful launch.
From other Sites:
- Successful product transfer from Third Party or other Abbott site to Baddi through gape assessment, equipment equivalency, and calculating scale-up factor.
Should involve in the following supervisory activities to support cross-function activities:
- To provide technical training to the Manufacturing and Packing team.
- Support for investigations (OOS/OOT/deviation) and market complaints to identify RCA and provide the technical solution to any process issue as part of CAPA.
- To perform a risk assessment and evaluate the change impact in case of any change in process/ equipment/ RM/PM.
- Provide technical support for externalization of the products to other Abbott sites/ TP/ LL.
Accountability / Scope:
- Product Technology Transfer from I&D/ TPM/ LL to Baddi.
- To provide technical support to the Baddi team in the regular commercials.
Education & Experience:
- M.Pharm (preferably in pharmaceutics) with 6-9 years experience.